FDA Adverse Event
Malfunction
Summary report: N
ID CORE XT
MDR report key: 12096982
·
Received June 30, 2021
Report
- Report Number
- 3006413195-2021-00005
- Event Type
- Malfunction
- Date Received
- June 30, 2021
- Date of Event
- April 22, 2021
- Report Date
- July 27, 2021
- Manufacturer
- PROGENIKA BIOPHARMA, S.A
- Product Code
- PEP
- UDI-DI
- 08437013457064
- PMA / PMN Number
- BP170154
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THE FALSE POSITIVE RESULT OBTAINED BY ID CORE XT IS NOT CONSIDERED A DISCREPANT RESULT OR MALFUNCTION. THERE IS A DEVIATION FROM THE PACKAGE INSERT INSTRUCTIONS REGARDING SAMPLE QUALITY. THE CUSTOMER IS REQUESTED TO EXTRACT AND ANALYZE A NEW SAMPLE THAT MEETS THE QUALITY REQUIREMENTS OF THE PACKAGE INSERT.
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS STILL ON-GOING. NO CONCLUSION IS AVAILABLE FOR THIS MALFUNCTION.
Description of Event or Problem · 1
THE CUSTOMER REPORTED A POSSIBLE DISCREPANCY. THE SEROLOGICAL PHENOTYPE WAS E- BUT WHEN TESTED WITH ID CORE XT RESULTED PHENOTYPE WAS E+.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 989783 | ID CORE XT | ID CORE XT | PEP | PROGENIKA BIOPHARMA, S.A | 1020220034 | 0203000023 | 08437013457064 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |